Trial Outcomes & Findings for Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer (NCT NCT03048942)

NCT ID: NCT03048942

Last Updated: 2026-07-21

Results Overview

Duration of progression free survival

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

158 participants

Primary outcome timeframe

Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.

Results posted on

2026-07-21

Participant Flow

Patients with HER2 negative metastatic breast cancer were recruited between 2014 and 2020 from NHS Trusts in the UK. First patient randomised December 2014 and last patient randomised March 2020.

None. Screening was as per eligibility criteria

Participant milestones

Participant milestones
Measure	Cabazitaxel 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle	Paclitaxel 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.
Overall Study STARTED	79	79
Overall Study COMPLETED	79	79
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cabazitaxel n=79 Participants 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle	Paclitaxel n=79 Participants 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.	Total n=158 Participants Total of all reporting groups
Age, Continuous	56 Years n=79 Participants	61 Years n=79 Participants	58 Years n=158 Participants
Sex: Female, Male Female	79 Participants n=79 Participants	79 Participants n=79 Participants	158 Participants n=158 Participants
Sex: Female, Male Male	0 Participants n=79 Participants	0 Participants n=79 Participants	0 Participants n=158 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
ECOG ECOG 0	53 Participants n=79 Participants	44 Participants n=79 Participants	97 Participants n=158 Participants
ECOG ECOG 1	26 Participants n=79 Participants	35 Participants n=79 Participants	61 Participants n=158 Participants
ER status ER negative	21 Participants n=79 Participants	20 Participants n=79 Participants	41 Participants n=158 Participants
ER status ER positive	58 Participants n=79 Participants	59 Participants n=79 Participants	117 Participants n=158 Participants
Previous docetaxel No previous docetaxel	46 Participants n=79 Participants	52 Participants n=79 Participants	98 Participants n=158 Participants
Previous docetaxel Yes previous docetaxel	33 Participants n=79 Participants	27 Participants n=79 Participants	60 Participants n=158 Participants
Presence of liver metastases at baseline No liver mets	33 Participants n=79 Participants	34 Participants n=79 Participants	67 Participants n=158 Participants
Presence of liver metastases at baseline Yes liver mets	46 Participants n=79 Participants	45 Participants n=79 Participants	91 Participants n=158 Participants
Previous treatment with CDK 4/6 iinhibitors No treatment with CDK 4/6 inhibitors	70 Participants n=79 Participants	68 Participants n=79 Participants	138 Participants n=158 Participants
Previous treatment with CDK 4/6 iinhibitors Yes treatment with CDK 4/6 inhibitors	9 Participants n=79 Participants	11 Participants n=79 Participants	20 Participants n=158 Participants

PRIMARY outcome

Timeframe: Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.

Duration of progression free survival

Outcome measures

Outcome measures
Measure	Paclitaxel n=79 Participants 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.	Cabazitaxel n=79 Participants 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Progression Free Survival	5.8 months Interval 4.6 to 6.9	6.7 months Interval 5.4 to 7.6

SECONDARY outcome

Timeframe: At the completion of 6 cycles of chemotherapy, which is after 18 weeks

Defined as stable disease rate + partial response rate+complete response rate according to RECIST 1.1 criteria

Outcome measures

Outcome measures
Measure	Paclitaxel n=79 Participants 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.	Cabazitaxel n=79 Participants 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Clinical Benefit Rate	83.5 percentage of participants Interval 73.5 to 90.9	78.5 percentage of participants Interval 67.8 to 86.9

SECONDARY outcome

Timeframe: At completion of 6 cycles of chemotherapy, which is after 18 weeks.

Objective response rate (ORR) is defined as complete response (CR) plus partial response (PR) as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan every 6 weeks. Tumours were assessed at baseline and compared to the response seen at the completion of treatment. Only responses seen within the 6 cycles of treatment e.g. up to and including the end of treatment tumour assessment are included in this measure. CR - Disappearance of all target lesions; PR \>=30% decrease in the sum of the longest diameter of target lesions.

Outcome measures

Outcome measures
Measure	Paclitaxel n=79 Participants 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.	Cabazitaxel n=79 Participants 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Objective Response Rate	36.7 percentage of participants Interval 26.1 to 48.3	41.8 percentage of participants Interval 30.8 to 53.4

SECONDARY outcome

Timeframe: Determined as the time from randomisation to death from any cause. Average survival rates for this population may be approximately 18 months.

Survival duration from randomisation to date of death.

Outcome measures

Outcome measures
Measure	Paclitaxel n=79 Participants 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.	Cabazitaxel n=79 Participants 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Overall Survival	18.2 months Interval 13.1 to 24.1	21.3 months Interval 16.1 to 30.1

SECONDARY outcome

Timeframe: Measured from from the date of the last day of trial treatment. approximately after progression which on average would be after 12 months.

Population: Not all patients went on to have second line cytotoxic chemotherapy after finishing trial treatment. Only those who went on to have second line treatment were analysed for this outcome measure. 65 patients who received cabazitaxel and 58 patients who received paclitaxel went on to have second line treatment.

time from randomisation to another chemotherapy treatment after confirmed progression.

Outcome measures

Outcome measures
Measure	Paclitaxel n=58 Participants 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.	Cabazitaxel n=65 Participants 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Time to Next Chemotherapy Treatment	7.2 months Interval 5.5 to 8.1	5.7 months Interval 5.1 to 7.6

SECONDARY outcome

Timeframe: Determined by time from randomisation to radiological partial response. This was sometimes seen after treatment end but all responses occurred by 8 months from randomisation therefore within 32 weeks.

Population: Only patients who had a response as per RECIST 1.1. Complete response (CR) - Disappearance of all target lesions; Partial response (PR) \>=30% decrease in the sum of the longest diameter of target lesions were analysed for this outcome measure. 37 patients who received cabazitaxel and 32 patients who received paclitaxel had a response (CR+PR). 7 patients (4 on cabazitaxel and 3 on paclitaxel) had their first response reported after the end of treatment and are included here but not in outcome 3.

Time taken for tumour burden to respond to treatment

Outcome measures

Outcome measures
Measure	Paclitaxel n=32 Participants 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.	Cabazitaxel n=37 Participants 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Time to Response	1.8 months Interval 1.5 to 3.0	2.7 months Interval 1.8 to 3.1

SECONDARY outcome

Timeframe: EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)

Population: All patients completed at least one questionnaire but some timepoints were missed leading to fewer than 158 being analysed at various timepoints.

EQ-5D-5L will be assessed at baseline, prior to cycle 3 and cycle 5 and at the end of treatment. The patients answer 5 questions which have 5 possible answers from no issue to extreme issue. The answers are given a code, 1, 2, 3, 4 or 5 with 1 for no issue through to 5 for extreme issues which results in a 5 digit 'health state' for that time point. Using a formula this is translated into the 'EQ-5D index value' where 1 is full health and 0 is the worst health. This is what is presented here, the lower the score the worse the quality of life.

Outcome measures

Outcome measures
Measure	Paclitaxel n=79 Participants 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.	Cabazitaxel n=79 Participants 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Assessment of EQ-5D-5L Questionnaire Baseline	0.78 Score on a scale Standard Deviation 0.2	0.76 Score on a scale Standard Deviation 0.23
Assessment of EQ-5D-5L Questionnaire Pre-cycle 3	0.81 Score on a scale Standard Deviation 0.87	0.8 Score on a scale Standard Deviation 0.17
Assessment of EQ-5D-5L Questionnaire Pre-cycle 5	0.79 Score on a scale Standard Deviation 0.19	0.87 Score on a scale Standard Deviation 0.1
Assessment of EQ-5D-5L Questionnaire End of Treatment	0.75 Score on a scale Standard Deviation 0.21	0.79 Score on a scale Standard Deviation 0.19

SECONDARY outcome

Population: All patients completed at least one questionnaire but some timepoints were missed leading to fewer than 158 being analysed at various timepoints

EQ-5D-5L VAS score was assessed at baseline, prior to cycle 3 and 5 and at the end of treatment. Patients are asked to score their health on a scale 0-100, the higher the score the better they are feeling.

Outcome measures

Outcome measures
Measure	Paclitaxel n=79 Participants 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.	Cabazitaxel n=79 Participants 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Assessment of EQ-5D-5L VAS Score Baseline	73.3 Score on a scale Standard Deviation 18.5	67.8 Score on a scale Standard Deviation 22.2
Assessment of EQ-5D-5L VAS Score Pre-cycle 3	71.0 Score on a scale Standard Deviation 16.2	73.2 Score on a scale Standard Deviation 16.1
Assessment of EQ-5D-5L VAS Score Pre-cycle 5	69.4 Score on a scale Standard Deviation 18.4	77.1 Score on a scale Standard Deviation 17.6
Assessment of EQ-5D-5L VAS Score End of Treatment	68.5 Score on a scale Standard Deviation 20.2	75 Score on a scale Standard Deviation 18.4

SECONDARY outcome

Population: All patients completed at least one questionnaire but some timepoints were missed leading to fewer than 158 being analysed at various timepoints.

FACT-B will be assessed at baseline, prior to cycle 3 and cycle 5 and at the end of treatment. The patients answer 37 questions which have 5 possible answers from not at all to very much. The answers are given a code, 0, 1, 2, 3 or 4 with 0 for not at all through to 4 for very much. The scores are reversed and then totalled to give a value out of 148. This is what is presented here, the higher the score the better the quality of life.

Outcome measures

Outcome measures
Measure	Paclitaxel n=79 Participants 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.	Cabazitaxel n=79 Participants 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Assessment of FACT-B Questionnaire Baseline	103.2 Score on a scale Standard Deviation 20.3	102.6 Score on a scale Standard Deviation 22.3
Assessment of FACT-B Questionnaire Pre-cycle 3	104.3 Score on a scale Standard Deviation 21.4	106.9 Score on a scale Standard Deviation 21.0
Assessment of FACT-B Questionnaire Pre-cycle 5	103.9 Score on a scale Standard Deviation 22.4	114.0 Score on a scale Standard Deviation 16.3
Assessment of FACT-B Questionnaire End of Treatment	103.4 Score on a scale Standard Deviation 22.5	108.4 Score on a scale Standard Deviation 20.1

Adverse Events

Cabazitaxel

Serious events: 27 serious events

Other events: 79 other events

Deaths: 69 deaths

Paclitaxel

Serious events: 24 serious events

Other events: 79 other events

Deaths: 70 deaths

Serious adverse events

Other adverse events

Additional Information

Prof Amit Bahl

University Hospitals Bristol and Weston NHS Foundation Trust

Phone: +44 (0)117 3426738

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The NHS Organisation agrees to treat the Results of the Study as confidential
Publication restrictions are in place

Restriction type: OTHER

Measure	Cabazitaxel n=79 participants at risk 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle	Paclitaxel n=79 participants at risk 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.
Gastrointestinal disorders Abdominal Pain	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Cardiac disorders Acute coronary syndrome	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Renal and urinary disorders Acute Kidney injury	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Infections and infestations Chest Infection	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	2.5% 2/79 • Number of events 2 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Respiratory, thoracic and mediastinal disorders Community Acquired pneumonia	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	3.8% 3/79 • Number of events 3 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Gastrointestinal disorders Diarrhoea	3.8% 3/79 • Number of events 3 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Respiratory, thoracic and mediastinal disorders Dizzy	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.5% 2/79 • Number of events 2 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	6.3% 5/79 • Number of events 6 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Respiratory, thoracic and mediastinal disorders Epistaxis	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Blood and lymphatic system disorders Febrile neutropenia	12.7% 10/79 • Number of events 12 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	2.5% 2/79 • Number of events 2 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
General disorders Fever	2.5% 2/79 • Number of events 2 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	2.5% 2/79 • Number of events 2 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Gastrointestinal disorders Generally unwell	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Nervous system disorders Headache	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
General disorders Hypersensitivity reaction	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Musculoskeletal and connective tissue disorders Increased pain left leg	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	2.5% 2/79 • Number of events 2 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Musculoskeletal and connective tissue disorders Lower lumbar pain	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Respiratory, thoracic and mediastinal disorders Lower Respiratory Tract Infection	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Skin and subcutaneous tissue disorders Maculo-papular rash	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Gastrointestinal disorders Nausea	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Infections and infestations Sepsis	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	2.5% 2/79 • Number of events 2 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
General disorders Oedema limbs	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Gastrointestinal disorders Perforated diverticulum	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Cardiac disorders Pericardial effusion	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Infections and infestations Line infection	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary embolus	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Injury, poisoning and procedural complications Right femur fracture	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Nervous system disorders Seizure	1.3% 1/79 • Number of events 1 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Gastrointestinal disorders Vomiting	3.8% 3/79 • Number of events 3 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	3.8% 3/79 • Number of events 3 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Renal and urinary disorders Urinary Tract Infection	1.3% 1/79 • Number of events 2 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years	0.00% 0/79 • Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years